Kornimate/medical-research-clean huggingface dataset:
the efficacy of front-of-package labelling schemes: an experimental study

Conditions: Diet Modification; Cardiovascular Diseases; Nutrition

Summary: this is an online study that aims to test the effectiveness of interpretative nutrition rating systems (inrs) such as the health star rating system (hsr or star system), traffic light system and warning labels (high sodium, saturated fat and sugar) proposed by health canada. the study will incorporate the use of a smartphone application (app), foodflip®, to help educate consumers on each inrs prior to their exposure on food packages.


Eligibility criteria:
inclusion criteria: * speak english as a primary language * reside in canada excluding the northern territories * are 18 years or over * provide informed consent * do at least some of the household grocery shopping * own a smartphone (version iphone 3 or later or android) * are able to complete the survey on a minimum screen size of 9.7 inches.
multi-disciplinary diagnosis and treatment process and evaluation system for children with sleep disordered breathing and malocclusion

Conditions: Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion

Summary: the aim of this study is to compare the efficacy and safety of drug therapy, tonsillar adenoidectomy only, orthodontic treatment only and tonsillar adenoidectomy plus orthodontic treatment in children with obstructive sleep apnea hypopnea syndrome (osahs) and malocclusion. in this study, we hope to improve children's osah in function, three-dimensional shape and subjective and objective symptoms of sleep breathing through tonsillar adenoidectomy plus orthodontic treatment.


Eligibility criteria:
inclusion criteria: 1. diagnosed as mild to moderate osahs 2. tonsil and/or adenoid hypertrophy 3. narrow dental arch and / or mandibular retrusion (anb value≥ 4.5) 4. the guardian / child can understand the study and sign the informed consent exclusion criteria: 1. patients with nasal obstruction disease 2. the pathological obesity 3. patients with systemic disease 4. patient with central sleep apnea/hypopnea syndrome
a study of the abuse potential of lasmiditan in participants who are recreational drug users

Conditions: Recreational Drug Use; Prescription Drug Abuse (Not Dependent)

Summary: the purpose of this study is to assess the abuse potential of study drug lasmiditan. lasmiditan will be compared to a marketed benzodiazepine, alprazolam (positive control), as well as to placebo (dummy substance that looks like lasmiditan or alprazolam without any active drug) to determine the potential for drug abuse. the dosages will be in tablet form and will be taken orally (by mouth). this study will last about 55 days, including screening. screening will occur within 28 days prior to qualification phase.


Eligibility criteria:
inclusion criteria: * are overtly healthy males or females, as determined by medical history and physical examination. * have a body mass index (bmi) of 18 to 32 kilograms per meter squared (kg/m²) inclusive, at the time of screening. * must be recreational drug user and agree not to consume any recreational drugs during the study. exclusion criteria: * have known allergies to lasmiditan, alprazolam, related compounds, or any components of the formulation, or a history of significant atopy. * are currently seeking or participating in treatment for addiction or substance-related disorders, or have recovered from substance abuse disorder. * are currently taking excluded prescription or over-the-counter (otc) medications. * have a history of significant sleep disorder, including sleep apnea or narcolepsy. * have a history of orthostatic hypotension, vertigo, syncope, or presyncope. * have a history of brain injury, including a history of concussions.
the clinical study of shr-a2009 for injection in patients with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this study is an open-label, phase i clinical trial of shr-a2009 in patients with advanced solid tumors. the whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.


Eligibility criteria:
inclusion criteria: 1. patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently; 2. have at least one measurable tumor lesion per recist v1.1; 3. ecog performance status of 0-1; 4. life expectancy ≥ 12 weeks; 5. adequate bone marrow and organ function. 6. subjects must voluntarily agree to participate in the trial and sign a written informed consent form. exclusion criteria: 1. patients with active central nervous system metastases or meningeal metastases; 2. ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug; 3. prior treatment with antibody-drug conjugate (adc) consisting of topoisomerase i inhibitors; 4. history of serious cardiovascular and cerebrovascular diseases; 5. severe infection within 4 weeks prior to the first dose; 6. adverse reactions of previous anti-tumor treatment have not recovered to grade ≤ 1 per nci-ctcae v5.0.
traditional dietary advice vs. mediterranean diet in ibs

Conditions: Irritable Bowel Syndrome

Summary: irritable bowel syndrome (ibs) affects 5-10% of the population, and incurs substantial health impairment and healthcare utilization. over 80% of individuals with ibs report food to trigger or aggravate symptoms, with many seeking to undertake dietary modifications. current guidelines recommend first-line therapy with the relatively straightforward traditional dietary advice, with the more complex and restrictive low fodmap diet reserved as second-line therapy. there is emerging data suggesting that the mediterranean diet may also improve the symptoms of ibs, although it has not yet been subject to any head-to-head randomized dietary trials to help position it within the treatment algorithm. given the relative ease of implementing the mediterranean diet, alongside its recognized cardio-metabolic and mental health benefits, studying its efficacy in ibs is attractive as it could potentially pave the way for another first-line dietary option being available to patients before escalating to the demanding and resource intensive second-line therapies. the investigators will perform a randomized trial comparing the clinical efficacy of traditional dietary advice vs. a mediterranean diet in ibs. following dietary randomization, participants will complete validated questionnaires to assess changes in ibs symptoms, quality of life, mood, somatic symptoms, nutritional status, as well as dietary satisfaction and adherence.


Eligibility criteria:
inclusion criteria: * ibs symptom severity scale(ibs-sss) \> 75 * online access * english literate exclusion criteria: * organic gastrointestinal diseases (e.g. inflammatory bowel disease, gi cancer, coeliac disease, microscopic colitis, bile acid diarrhoea) * major abdominal surgery (except laparoscopy, appendectomy, cholecystectomy) * history of eating disorder * body mass index \<20 * current dietary interventions * current use of opioids/antibiotics * titrating dose of neuromodulators * severe systemic disease (e.g. cardiac, renal, respiratory, psychiatric) necessitating frequent medical consultations/hospitilisations * pregnant * diabetes mellitus * scleroderma * memory impairment
efficacy and safety of bupropion for treatment of adolescent smoking

Conditions: Tobacco Dependence

Summary: the purpose of this study is to determine: 1) the short-term clinical efficacy and safety of bupropion for helping adolescent tobacco smokers quit, and 2) the role of withdrawal symptoms in the maintenance of smoking in adolescents.

this 10-week study consists of an unassisted (pretrial) acute tobacco withdrawal (aw) phase and a 7-week randomized double-blind placebo-controlled trial of bupropion (300 mg/day) for tobacco dependence. neuropsychological examinations will be conducted at baseline, during acute withdrawal, and during treatment (incl. early withdrawal) with bupropion. we expect smoking cessation in approximately 25% of the active medication group and significant overall smoking reduction. we postulate that bupropion will also reduce the irritability, depressed mood and anxiety symptoms that typically occur during tobacco withdrawal. we expect to observe optimal cognitive performance, (i.e., attention, memory), and affective state during satiety, impairment during pre-treatment abstinence, and intermediate level cognitive performance in the abstinent active-treatment group. because limited data are available on cognitive tasks in adolescent smokers, a non-smoking group will be included in order to establish the validity and appropriateness of our paradigm with a normative sample.

Eligibility criteria:
inclusion criteria: * more than 100 lbs * iq greater than 80 * general good health * not pregnant * non-smoker: no cigarettes in last 6 months, less than 5 in lifetime * smokers: smoke more than 6 cigarettes per day for at least 6 months exclusion criteria: * cardiac, central nervous system (cns) or severe psychiatric disorder * psychoactive medications (including nicotine replacement) * substance use disorder

Keywords: randomized double-blind placebo-controlled
study of copeptin as a diagnostic marker for acute pancreatitis

Conditions: Acute Pancreatitis; Pancreatitis

Summary: the purpose of this study is to investigate if there is an association between copeptin level in serum and the severity of pancreatitis and if copeptin can be used as a predictor for organ failure and pancreatic necrosis with or without superinfection.

acute pancreatitis may range from mild to severe disease with high mortality in case of infected pancreatic necrosis. due to its rising incidence it remains an important healthcare problem in europe and us. the assessment of the severity of pancreatitis is crucial for the further management and the prognosis. several quite complex scores like ranson or apache ii scores has been used in the past with reasonable sensitivity for necrosis or superinfection as well as inflammation markers like c-reactive protein. copeptin, the c-terminal part of antidiuretic hormone, is a relatively stable peptide in blood circulation. several studies investigated copeptin in the presence of systemic inflammatory response syndrome (sirs) or sepsis, myocardial infarction, lower respiratory tract infection and cerebral stroke. copeptin has shown to be a helpful prognostic marker in these diseases. the aim of this prospective study is to investigate whether copeptin can be used to assess the severity of pancreatitis.

Eligibility criteria:
inclusion criteria: * diagnosis of acute pancreatitis * written informed consent * inpatient treatment exclusion criteria: * time interval between onset of abdominal symptoms and study inclusion \>96h * patients unable to consent

Keywords: copeptin vasopressin antidiuretic hormone (adh)
daratumumab in treatment of pgnmid and c3 gn

Conditions: Membranoproliferative Glomerulonephritis

Summary: this study is being done to see if daratumumab is safe and effective in the treatment of proliferative glomerulonephritis with monoclonal immune deposits (pgnmid) and c3 glomerulopathy associated with monoclonal gammopathy (c3gn). this is an inflammatory disease in the kidney due to the production of abnormal proteins. there are no known standard effective treatments for patients with pgnmid and c3gn secondary to monoclonal gammopathy. these diseases are caused by abnormal production of proteins (monoclonals) by abnormal clones. daratumamb has been shown to be effective in treating patients with multiple myeloma a disease which also caused by over production of monoclonal proteins from abnormal clones. everyone in this study will receive daratumumab.

this study is an open-label phase 2 trial of the safety and efficacy of daratumumab, in the treatment of pgnmid and c3gn associated with monoclonal gammopathy. subjects will be screened at outpatient nephrology clinic visit appointments and interested qualified subjects will be consented and offered participation in this trial. once consent has been obtained baseline values will be established and subjects will begin treatment and follow-up for the next 12 months. daratumumab will be administered once weekly for 8 weeks and then once every 2 weeks for 8 additional doses. patients will be followed for a total of 12 months (6 months after the last infusion). a final visit for evaluation and collection of lab samples will be conducted at the end of the study.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years of age * renal biopsy read at mayo clinic confirming the diagnosis of pgnmid or c3 gn * in cases of c3gn serum electrophoresis with immunofixation should confirm presence of monoclonal gammopathy * proteinuria ≥ 1000 mg over 24 hours * egfr ≥ 20 ml/min/sa * subjects able and willing to give informed consent exclusion criteria: * pregnancy * hepatitis b or c, hiv * multiple myeloma * anemia with hgb \< 8.5 g/dl * thrombocytopenia with platelet count \< 100,000 * leukopenia with wbc \< 3.5 * any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication * unable to provide consent * patients receiving therapy with oral prednisone or glucocorticoid equivalent in the last 6 weeks * patients who had received immunosuppressive therapy including cyclophosphamide, mmf, cyclosporine, tacrolimus or azathioprine in the last 3 months * patients who received rituximab previously with cd20 count of zero at the time of enrollment
primary prevention of infections related to chambers implantable catheter by a taurolodine lock in patients with cancer receiving parenteral nutrition

Conditions: Cancer; Infection

Summary: the therapeutic management of patients with cancer often requires the establishment of a chamber implantable catheter. infections are the main complication of these catheters. these infections may be responsible for a significant impairment of quality of life for patients, and may increase the frequency and duration of hospitalizations. the rate of mortality from these infections is about 17%. the objective of this study is to evaluate the efficacy of a 1.35% taurolidine lock / 4% citrate (taurolock®) in the primary prevention of infections related to chambers implantable catheter (ircic) in cancer patients receiving parenteral nutrition. this is a, randomized, double-blind clinical trial comparing the incidence of ircic in patients receiving taurolidine lock or concession the usual procedure of rinsing with saline (placebo) (pulsed rinsing with 20 ml of serum physiological and clamping catheter positive pressure). the lock will be instilled after the end of the session iv treatment (chemotherapy, parenteral nutrition, transfusion) before closing the catheter. the primary endpoint will be the rate ircic in both groups.


Eligibility criteria:
inclusion criteria: * patients aged 18 years and over * patients with solid cancer * patients with implantable catheter * patients receiving parenteral nutrition * patient affiliated to a social security scheme or beneficiary of such a regime exclusion criteria: * patients refusing to participate in the protocol * patients already receiving preventive lock of ircic * known citrate or (cyclo) allergy -taurolidine * patients taking other drugs with known contraindications against the citrate or cyclotaurolidine. * participation in another protocol for the prevention of infections associated with central venous catheters * patients who did not sign the consent * patient with a status of socio-legal protection

Keywords: taurolock® infections related to chambers implantable catheter patients with cancer receiving parenteral nutrition
acquired chronic erosive gingivitis: clinical relevance of papillary gingival biopsy

Conditions: Gingival Diseases; Gingivitis; Autoimmune Diseases; Oral Lichen Planus

Summary: chronic erosive gingivitis is a syndrome (cegs) that combines severe gingival inflammation and gingival erosion. the term "desquamative gingivitis" is often used in the literature to define chronic erosive gingivitis. however, this definition is inappropriate because the pathophysiological process at the origin of this gingival disease does not induce a desquamation but rather a loss of gingival substance, namely erosion, concerned wholly or in part of the gingival epithelium. in most clinical situations, chronic erosive gingivitis is an oral manifestation of a general disease with immune dysfunction. the most frequently described diseases are gingival lichen and autoimmune bullous diseases (aibd). in 2018, as part of a monocentric study, we were the first to detail an original papillary gingival biopsy protocol, non-iatrogenic, perfectly suited to the anatomopathological examinations necessary for the diagnosis of aibd gingival expression. the cegs early detection by odontologists avoid delayed diagnosis and allows patients to be referred to the closest aibd reference center. hypothesis/objective a bicentric study was conducted, to evaluate the clinical relevance of this protocol, including the differential diagnosis of the cegs. research was supplemented by carrying out a systematic review of the literature to compare the contributive capacity diagnostic of the papillary biopsy technique with other gingival sample methods (attached gingival tissue, mucosa). method a retrospective bicentric observational study was conducted from october 2011 to july 2019, in two departments of oral medicine of two public hospitals in paris (university hospital - bretonneau in paris and henri mondor in créteil; france). these two departments are specialized in the diagnosis and management of oral pathology; that of the henri mondor hospital is an aibd reference center. the literature review was developed in accordance with prisma recommendations. it was conducted on pubmed - medline and cochrane oral health group and included all existing publications from 1935 until august 2019. a manual search of publications from the unpublished literature was also conducted.


Eligibility criteria:
inclusion criteria: • patients referred on an outpatient basis by the physician or the dental surgeon, suffering from an acute erosive gingivitis, regardless of age and general health. exclusion criteria: • patients referred on an outpatient basis by the physician or the dental surgeon, with a histological examination and immunofluorescence (dif) already done previously, and patient under corticosteroid therapy which is skewing the immunofluorescence (dif) data.

Keywords: erosive gingivitis biopsy desquamative gingivitis gingival disease oral lichen planus mucous membrane pemphigoid benign pemphigus vulgaris
the effectiveness of "care coaching model" as an effort to empower type 2 diabetes mellitus patients

Conditions: Diabetes Type 2

Summary: in indonesia and others countries, only 30.8% patients with type 2 diabetes mellitus (t2dm) achieved glycemic control with hba1c \<7%. optimal pharmacological treatment alone does not guarantee an optimal outcome, therefore it should be combined with lifestyle management. health coaching helps t2dm patients increase self awareness to improve and maintain behavior which play a role in self-management. this study aims to evaluate the impact of health coaching on glycemic control on t2dm patients.

subjects randomized into 2 groups: control and intervention group. all subject received education class in top of standard treatment. intervention group received additional personal health coaching. education and health coaching was given for 12 sessions every 2 weeks with 12 different themes for each session. health coaching were given by international certified health coach. laboratory examination and questionnaire collected at baseline, 3 and 6 months after intervention.

Eligibility criteria:
inclusion criteria: * t2dm patients * aged 30-60 years old * hba1c \> 7.5% within the past 3 months * able to write and read. exclusion criteria: * patients with cognitive disease (such as dementia) * having hearing problem or sight problem * unable to live independently on daily basis * having disease that may affect hba1c result (eg: hemolytic anemia)

Keywords: diabetes mellitus health coaching
jaguar trial (outside united states; ous): objective analysis to gauge evar outcomes through randomization

Conditions: AAA; AAA - Abdominal Aortic Aneurysm

Summary: prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary evar in a real-world population. patients will be randomized into two device cohorts and compared across the primary endpoints. patients will be followed procedurally to discharge, at 1, 6, 12 months and annually through to 5 years (total follow-up commitment).


Eligibility criteria:
inclusion criteria: * adult age 21 and older * subjects with minimum of 2 year life expectancy * subjects have signed the informed consent document * subjects with unruptured infrarenal aaa who are assessed by the investigator to be eligible for endovascular abdominal aortic aneurysm repair with the trial devices. * patient must be able and willing to comply with all required follow-up exams. exclusion criteria: * currently participating in another trial where the primary endpoint has not been reached yet. * known allergy to any of the device components * pregnant (females of childbearing potential only) * known connective tissue disorders * known active infection * subjects with pre-existing evar, i.e., in need of repair/intervention of a previously failed evar. * patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
can intermittent fasting mimic the metabolic and cardiovascular and anti-aging effects of calorie restriction?

Conditions: Obesity; Overweight

Summary: the purpose of intermittent fasting study is to investigate whether intermittent fasting could decrease the chronic inflammation levels in overweight/obese people.

the primary objective of this study is to determine whether or not if reduces the level of chronic inflammation as evidenced by a decrease in high sensitive c-reactive protein (hscrp), as the main outcome measure

Eligibility criteria:
inclusion criteria: * the participants in this study will be 50 men and women in the 30 to 65 year age range, who have a bmi in the high normal to moderately obese range (i.e. 24 to 35 kg/m2), * participants who are eating usual us diets and are sedentary to moderately active (i.e. not exercise trained). exclusion criteria: * history of any chronic disease process that could interfere with interpretation of results * smoking, pregnancy, alcoholism, psychiatric problems, life situations that would interfere with study participation and compliance.

Keywords: intermittent fasting obesity calorie restriction